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Real-world Data: Tildrakizumab Restores and Maintains Wellbeing of PsO Patients

Tildrakizumab (Ilumetri, Almirall) restores the level of wellbeing of patients with moderate-to-severe plaque psoriasis to that of the general population as early as Week 16 after initiating the treatment, according to new data from the POSITIVE real-world study.

This fundamental benefit was maintained for up to 1 year of treatment.

These results were presented at the International Federation of Psoriasis Associations (IFPA) Conference 2024 in Stockholm, Sweden.

The POSITIVE study also showed that treatment with tildrakizumab led to notable improvements in skin clearance, particularly in sensitive areas (scalp, nail and palms/soles), as well as in high-burden symptoms (itch, pain, joint pain and fatigue). Following 52 weeks of treatment, almost 6 out of 10 patients achieved a Psoriasis Area and Severity Index (PASI) ≤1 response, with no new safety signals observed, consistent with previous studies.

“The impact of psoriasis on patients’ wellbeing cannot be overstated. It affects their overall health, psychological state, and social life,” says Prof. Dr. Ulrich Mrowietz, from the Psoriasis Center at the University Medical Center Schleswig-Holstein, Campus Kiel, in a news release.“The interim results from the POSITIVE study are promising, they demonstrate that treatment with tildrakizumab restores patients’ well-being within 16 weeks and maintains it for at least one year. Additionally, significant improvements are observed in skin condition, high-burden symptoms, and sensitive areas. This underscores tildrakizumab’s potential to alleviate the profound burden of psoriasis on daily life.”

The POSITIVE study uses the 5 item World Health Organization Wellbeing Index, WHO-5, a questionnaire that assesses health-related subjective psychological wellbeing in a variety of chronic diseases. The study will also use at the FamilyPso questionnaire to evaluate the impact of the disease on the family environment, and the Physician’s Satisfaction Score to measure physician wellbeing.

This ongoing study has enrolled 782 adults with moderate-to-severe psoriasis at multiple sites in Europe, including Austria, Belgium, France, Germany, Italy, Spain, Switzerland, The Netherlands, and the United Kingdom. The study will follow these patients for 24 months in their treatment with tildrakizumab

“These findings represent a significant milestone in our ongoing efforts to address the needs of patients and dermatologists to treat chronic dermatological conditions and help improve the patients’ health and wellbeing. The POSITIVE study demonstrates not only the efficacy of Ilumetri® in clearing skin but also its impact on enhancing patients’ overall wellbeing, which ultimately can contribute to the successful treatment enabling patients to get their lives back,” adds Dr. Volker Koscielny, Chief Medical Officer at Almirall.

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